Federal Register - August 11, 2021
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Fuente: Federal Register
Federal Register / Vol. 86, No. 152 / Wednesday, August 11, 2021 / Proposed Rules the application of E.O. 13132. The proposed rule does not have substantial direct effects on the States, on the relationship between the national government and the States, or the distribution of power and responsibilities among the various levels of government.
Executive Order 13175, Consultation and Coordination With Indian Tribal Governments This proposed rule does not have tribal implications warranting the application of E.O. 13175. It does not have substantial direct effects on one or more Indian tribes, on the relationship between the Federal government and Indian tribes, or on the distribution of power and responsibilities between the Federal government and Indian tribes.
Paperwork Reduction Act of 1995
This action does not impose a new collection of information requirement under the Paperwork Reduction Act of 1995 44 U.S.C. 35013521.
Regulatory Flexibility Act The Administrator, in accordance with the Regulatory Flexibility Act, 5
U.S.C. 601612, has reviewed this proposed rule, and by approving it, certifies that it will not have a significant economic impact on a substantial number of small entities.
DEA proposes placing the substance mesocarb, including its isomers, salts, and salts of isomers, in schedule I of the CSA. This action is being taken to enable the United States to meet its obligations under the 1971 Convention.
If finalized, this action would impose the regulatory controls and administrative, civil, and criminal
sanctions applicable to schedule I
controlled substances on persons who handle manufacture, distribute, reverse distribute, import, export, engage in research, conduct instructional activities or chemical analysis with, or possess, or propose to handle, mesocarb.
According to HHS, mesocarb has a high potential for abuse, has no currently accepted medical use in treatment in the United States, and lacks accepted safety for use under medical supervision. DEAs research confirms that there is no commercial market for mesocarb in the United States.
Additionally, queries of DEAs STRIDE/
STARLiMS and the NFLIS databases on May 26, 2021, did not generate any reports of mesocarb, suggesting that it is not trafficked in the United States.
Therefore, DEA estimates that no United States entity currently handles mesocarb and does not expect any United States entity to handle mesocarb in the foreseeable future. DEA concludes that no United States entity would be affected by this rule if finalized. As such, the proposed rule will not have a significant effect on a substantial number of small entities.
Unfunded Mandates Reform Act of 1995
On the basis of information contained in the Regulatory Flexibility Act section above, DEA has determined and certifies pursuant to the Unfunded Mandates Reform Act UMRA of 1995
2 U.S.C. 1501 et seq. that this action would not result in any Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector of $100,000,000 or more adjusted annually for inflation in any
1 year . Therefore, neither a Small Government Agency Plan nor any other action is required under provisions of the UMRA of 1995.
List of Subjects in 21 CFR Part 1308
Administrative practice and procedure, Drug traffic control, Reporting and recordkeeping requirements.
For the reasons set out above, 21 CFR
part 1308 is proposed to be amended to read as follows:
PART 1308SCHEDULES OF
CONTROLLED SUBSTANCES
1. The authority citation for 21 CFR
part 1308 continues to read as follows:
Authority: 21 U.S.C. 811, 812, 871b, 956b, unless otherwise noted.
2. Section 1308.11 is amended by redesignating paragraphs f7 through 10 as paragraphs f8 through 11, and adding a new paragraph f7 to read as follows:
1308.11
Schedule I.
f
7 Mesocarb N-phenyl-N-3-1phenylpropan-2-yl-1,2,3-oxadiazol-3ium-5-ylcarbamimidate. 15.
1227XXXXXXXXXXXXXXXXXX
f Stimulants. Unless specifically excepted or unless listed in another schedule, any material, compound, mixture, or preparation which contains any quantity of the following substances having a stimulant effect on the central nervous system, including its salts, isomers, and salts of isomers:
1 Aminorex Some other names: aminoxaphen; 2-amino-5-phenyl-2-oxazoline; or 4,5-dihydro-5-phenly-2-oxazolamine
2 N-Benzylpiperazine some other names: BZP, 1-benzylpiperazine
3 Cathinone
Some trade or other names: 2-amino-1-phenyl-1-propanone, alpha-aminopropiophenone, 2-aminopropiophenone, and norephedrone
4 Fenethylline
5 Methcathinone Some other names: 2-methylamino-propiophenone; alpha-methylaminopropiophenone; 2-methylamino-1phenylpropan-1-one; alpha-N-methylaminopropiophenone; monomethylpropion; ephedrone; N-methylcathinone;
methylcathinone; AL464; AL422; AL463 and UR1432, its salts, optical isomers and salts of optical isomers
6 cis-4-methylaminorex cis-4,5-dihydro-4-methyl-5-phenyl-2-oxazolamine
7 N-ethylamphetamine
8 N,N-dimethylamphetamine also known as N,N-alpha-trimethyl-benzeneethanamine; N,N-alpha-trimethylphenethylamine
Anne Milgram, Administrator.
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